Gene Expression in Cumulus Cells to Predict Pregnancy

The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.

The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.

Inclusion Criteria:

• Aged 21-39 years
• IVF cycle 1 or 2
• BMI <35
• Fertilization method: ICSI and/or IVF
• Day 3 or day 5 embryo transfer
• Treatment cycle intended for single or double embryo transfer
• Use own oocytes, not oocyte donor
• ≥ 3 embryos at final assessment
• Donor sperm acceptable
• Willing to comply with protocol and study procedures

Exclusion Criteria:

• Polycystic Ovarian Syndrome
• Presence of fibroid(s): >4 cm intramural or submucosal fibroids
• History of chemotherapy or radiation to the abdomen or pelvis
• Use of donor oocytes
• Use of reinseminated oocytes
• Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
• Concurrent participation in another clinical study
• (Male): Surgically removed sperm
• (Male): <5 million sperm count